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Due Diligence Solutions
ELIQUENT understands the complex regulatory environment within which life sciences transactions take place. ELIQUENT regularly partners with investors to evaluate potential issues and regulatory risks that may be identified during life sciences transactions. Our team of experts provide investors with extensive research, regulatory history assessments, and recommendations on the path forward for potential deals that require regulatory risk analyses before and after decisions and transactions
ELIQUENT’s due diligence services are more than a compilation of public data – we go a step further by enabling the vast institutional knowledge of our regulatory experts to provide in-depth analyses tailored to our clients’ specific needs. ELIQUENT’s multidisciplinary team uses its extensive expertise to perform risk assessments that take into account business objectives, transaction timelines, and the industry and regulatory landscape. The result is an unbiased expert analysis of both expected and unexpected regulatory risks
Unlocking Success
ELIQUENT’s due diligence solutions are tailored to the unique needs of the life science sector – empowering clients to confidently navigate opportunities. Our comprehensive services support strategic decision making for both buy-side and sell-side transactions.
Buy-Side Transactions
Our buy-side due diligence solutions empower investors with comprehensive insights to confidently navigate opportunities and achieve strategic objectives.
Scientific Rigor
With experience across the landscape of therapeutic areas and modalities, the ELIQUENT team provides the technical and scientific expertise investors need when considering a life sciences transaction.
Risk Mitigation
Investing in the life science arena comes with inherent risks. We go beyond identifying risks by providing strategic recommendations to mitigate them effectively, safeguarding your investments.
Market Intelligence
ELIQUENT’s industry knowledge and regulatory expertise offers invaluable market insights, enabling you to anticipate trends, assess competitive landscapes, and capitalize on emerging opportunities.
Sell-Side Transactions
ELIQUENT provides clarity and an objective viewpoint, thereby maximizing value in a transaction, and empowering companies to make informed decisions.
Program Roadmap
ELIQUENT partners with companies to evaluate, prioritize, and optimize commercial assets and programs. By identifying areas for improvement and value enhancement, our team of experts create a roadmap to maximize the prospects for successful regulatory outcomes.
Risk Assessment
Our in-depth assessments go beyond identifying regulatory risks – the ELIQUENT team delivers strategic and technical recommendations for system-wide quality and regulatory enhancements.
Industry Insights
ELIQUENT provides companies with critical insights by monitoring and analyzing the life sciences sector for emerging trends, evolving regulatory reforms, and changes to the competitive landscape.
Strategic & Technical Guidance
ELIQUENT’s due diligence services include research and analysis of the following potential data sources:
Product Development
Evaluation of clinical development plans, including review of clinical and nonclinical data, FDA correspondence, safety reporting, and sponsor proposals for future clinical studies.
Pathway Evaluation
Determine eligibility for special designation(s), including priority review, fast track, accelerated approval, breakthrough therapy designation, and regenerative medicine advanced therapy designation.
Regulatory Submissions
Review of pending product submissions to assess completeness and approval prospects, including FDA information requests, mid and late-cycle meetings, advisory committee outcomes, labeling negotiations, and inspectional results.
Compliance Status
Analysis of target company’s FDA compliance and enforcement history, including a review of FDA correspondence relating to compliance matters and identification of outstanding or pending compliance and remediation actions.
Distribution & Supply Chain
Assessment of import-export practices, supply chain audit reports, outsourcing arrangements, and distribution procedures.
Preclinical & Clinical Quality Systems
Assessment of compliance with FDA current good laboratory practice (GLP) and good clinical practice (GCP) regulations.
Reporting Requirements
Confirm that the target company has complied with all requirements for registration, authorization, filing, and listing associated with approved products, including user fee payments and fulfillment of postmarket obligations.
Quality Manufacturing
Evaluation of the target company’s compliance with FDA quality and manufacturing regulations related to inspections, standard operating procedures, quality assurance activities, and relevant contract manufacturers.
Adverse Event Reporting
Review of adverse event reports (AERs) and good manufacturing practice complaints to ensure that the target company has taken appropriate measures for review and investigation.
Marketing & Promotion
Evaluation of promotional practices and marketing materials, including labeling claims, promotion of unapproved products or off-label uses, and related FDA correspondence or enforcement actions.
Regulatory Resources.
Unlock ELIQUENT Excellence.
View or download ELIQUENT’s Due Diligence Solutions Information Sheet to explore our integrated service offerings and learn how our team of experts unlocks regulatory excellence.
Due Diligence Info Sheet
View or download ELIQUENT’s Due Diligence Solutions Information Sheet to explore our integrated service offerings.
Due Diligence News Release
Read ELIQUENT’s news release announcing the firm’s expanded Due Diligence Solutions.
Unmatched Expertise
ELIQUENT’s unprecedented assembly of regulatory leaders, industry experts, and technical specialists collaborate seamlessly throughout the product lifecycle. Together, we create a full-service model that equips clients with a premier regulatory resource.
Regulatory
Affairs
ELIQUENT’s life science experts work as teams specializing in drugs and biological products, medical devices and combination products, and advanced therapies. Together, they provide strategic and technical guidance on product development, regulatory review, and postmarket requirements across therapeutic areas, modalities, and global markets.
Quality
& Compliance
ELIQUENT provides services that are recognized as best in class by companies seeking to strengthen their quality management systems. Experts specialize in corporate quality and compliance systems; FDA inspections, communication, and enforcement processes; and the complete spectrum of compliance and enforcement-related actions.
Talent
Solutions
ELIQUENT’s comprehensive capabilities are amplified by a network of ready to deploy professionals with an expansive range of expertise. The hand-picked global consultant network supports and enhances ELIQUENT’s due diligence solutions by delivering the expertise, credentials, and language- or region-specific skill set clients need to unlock success.
ELIQUENT Experience
Explore real-world examples of ELIQUENT’s expertise with our case studies. Discover how we’ve helped clients overcome challenges, achieve their goals, and drive tangible results. From innovative strategies to impactful solutions, each case study offers valuable insights into our approach and capabilities.
CASE STUDY: Venture Capital Investment
in Novel Bacteriophage Development Space
Venture Capital Investor conducting diligence on an early-stage biopharmaceutical company engaged in a unique and challenging development space focused on novel natural and engineered phage therapies that target specific pathogenic bacteria. READ MORE
CASE STUDY: Private Equity Diligence of Multiple Excipient
Manufacturing Operations & Integration Potential
Private equity investor required quality/compliance expertise to assess excipient manufacturing operations, ramifications from a prior FDA enforcement action, and quality systems across numerous facilities both on-site and through a desktop audit. READ MORE
CASE STUDY: Global Medical Device Firm’s Acquisition &
Integration of Another Medical Device Manufacturer
Engaged by a global medical device company to assess the regulatory and compliance risks/opportunities associated with the product portfolio and pipeline of another global medical device company for a potential acquisition. READ MORE
CASE STUDY: Sell-Side Assessment of Vaccine Manufacturer
Preparing for Third-Party Diligence Following Key Data Release
Support an early-stage biotech company by providing a clinical and regulatory review in anticipation of third-party diligence following proof-of-concept data release. Engagement included strategic clinical and regulatory review of its development history…READ MORE
Ready for regulatory clarity? Contact us.
Unlock Opportunity
As one of the world’s leading economies, Japan offers life science innovators the unique opportunity to expanded market potential within a supportive regulatory environment. Together with ELIQUENT’s team of regulatory experts, clients leverage the strategic advantages of Japan’s regulatory landscape.
Thriving Pharma Economy
At $95 billion in value, Japan is the third-largest pharmaceutical market in the world, behind only the United States and China.
Growing Market Demand
An aging society and growing life expectancy, combined with Japan’s population size, drive demand for medical product development.
Regulatory Optimization
Accelerated approval pathways, including the Sakigake Designation Scheme, have helped expedite the regulatory process.
Support for Innovation
The Japanese government actively fosters an environment of innovation by reducing past barriers and creating incentives for life science innovators.
Global Harmonization
Japan’s harmonization with international regulatory standards has simplified the global development process for life science companies.
Enhanced IP Protections
New intellectual property protections benefit life science innovators by safeguarding investments in innovation.
Strategic Storytelling
ELIQUENT understands that the best stories are built through collaboration. Our medical writers partner with your internal teams to build a story that positions your product for success. This collaborative approach captures your product’s journey, prioritizes your business objectives, and builds a compelling narrative that resonates with regulators.
Accelerate Time to Market
Effective medical writing anticipates potential questions or objections from regulators and addresses them within the narrative. By complying with regulatory requirements the first time around, ELIQUENT’s Medical Writing Solutions streamline the approval process, reduce delays, and accelerate your product’s journey from concept to market.
Expand Global Market Entry
Entering global markets involves more than just innovative products – it requires precise, clear, and regulatory-compliant documentation. ELIQUENT’s medical writing team distills complex scientific data into accessible, authoritative documents that meet the regulatory requirements of international regulatory bodies.
Regulatory Resources.
Unlock ELIQUENT Excellence.
View or download ELIQUENT Japan’s Regulatory Solutions Information Sheet to explore our integrated service offerings and learn how our team of experts unlocks regulatory excellence.
Info Sheet
View or download ELIQUENT’s Japan Regulatory Solutions Information Sheet to explore our integrated service offerings.
News Release
Read ELIQUENT’s news release announcing ELIQUENT Japan’s new trade name.